BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 40/58 ALTRX LINER +4N

    MDR report key: 2163209 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12326
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K072963
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STERILIZATION CERTIFICATION FOR THE KNOWN PRODUCT/LOT COMBINATION DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. THE PRODUCT/LOT COMBINATION FOR THE FEMORAL HEAD REQUIRED TO REVIEW THE CERTIFICATION WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED INFECTION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN 40/58 ALTRX LINER +4N ALTRX LINERS LPH DEPUY ORTHOPAEDICS, INC. NA FL2HC1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention